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This study aims to determine whether systemic oxygen therapy delivered through face mask would have beneficial effects on the healing of corneal epithelial wound in post-vitrectomy diabetic patients. It will be a prospective, randomised interventional clinical study conducted on diabetic patients indicated for vitrectomy. Rationale of this study is to see if systemic oxygen delivered via face mask will hasten the resolution of corneal epithelial defects, which may either be iatrogenic (surgically-induced intra-operatively to enable clearer visualisation for the surgeon) or spontaneous (due to corneal epithelial fragility which is commoner in diabetics)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Group | Active Comparator | topical Maxitrolâ„¢ six-hourly and homatropine 2% six-hourly |
|
| Oxygen Group | Experimental | standard medical treatment of topical Maxitrolâ„¢ six-hourly and homatropine 2% six-hourly, plus systemic oxygen via simple face mask at 10 litres/min for one hour, in 12-hourly sessions for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean corneal epithelial wound healing time (in days) | 1 to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Age of subject as a factor influencing wound healing time | 1-7 days | |
| Glycemic control of subject (measured by glycated hemoglobin, HbA1c) | 1-7 days | |
| Duration of surgery and its influence on wound healing time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wee-Min Teh, MD | Universiti Sains Malaysia | Principal Investigator |
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| Homatropine 2% eye drops thrice daily | Drug |
|
| Oxygen gas | Drug |
|
| 1-7 days |
| Duration of diabetes mellitus (measured in years) and its influence on wound healing time | 1-7 days |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D009355 | Neomycin |
| C049064 | Maxitrol |
| C100236 | homatropine |
| C041364 | nitrox |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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